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Trial registered on ANZCTR

Registration number

ACTRN12623000679684

Ethics application status

Approved

Date submitted

9/05/2023

Date registered

23/06/2023

Date last updated

23/06/2023

Date data sharing statement initially provided

23/06/2023

Date results provided

23/06/2023

Type of registration

Retrospectively registered

Titles & IDs

Public title

The mindful pregnancy and mother-baby relationship project

Scientific title

Investigating the value of mindfulness to support maternal mental health and mother-infant relationship during pregnancy and post-birth

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

The Prenatal Mindfulness Relationship-Based (PMRB) program

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prenatal and postnatal depression

Prenatal and postnatal anxiety

Prenatal and postnatal stress

Maternal mindfulness

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Reproductive Health and Childbirth

Childbirth and postnatal care

Public Health

Health promotion/education

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The online weekly 9-week Prenatal Mindfulness- Relationship-Based (PMRB) program

a) Informational materials used
The PMRB program draws upon the eight-week Mindfulness-Based Stress Reduction (MBSR) developed by Dr Kabat-Zinn in the early 1980s at the University of Massachusetts Medical Center, the first and perhaps the most well-known mindfulness-based intervention to gain empirical support in the treatment of psychological symptoms. The background of the program is described in my book (Routledge, 2021).
In the PMRB program, the teaching of mindfulness is integrated with the following
knowledge:
• Breathing technique and meditation, mind-body pain and stress coping strategies for childbirth and awareness skills for coping with daily life stress.
• Prenatal and perinatal education, including prenatal development and the baby as a sentience being, basic knowledge of psychobiological processes of pregnancy, childbirth, postpartum adjustment, breastfeeding/feeding, psychobiological needs of the baby, and mother-baby sensorimotor modulation techniques during pregnancy using maternal touch, vocalization, and infant’s movements.
b) Procedures and activities.
Formal mindfulness meditation instruction is given by the program conductor (myself) and practiced in each class for the last 20-25 minutes, followed by the participants feedback of their experience. A key innovative element of the PMRB is the focus on mother-baby connection from a new mind-body perspective based on the mother’s awareness of her body (interoception) as well as of her unborn baby as a sentient being, capable of engaging in bidirectional interactions. This reflects a new concept of prenatal attachment based on shifting attention from when “the baby arrives to the baby is already here and I am connected to my baby”. In addition to attending the online classes, participants are asked to commit to practicing some home exercises, including free of charge guided mindfulness meditation videos from YouTube or created by me and particularly designed for pregnancy throughout the course. Furthermore, as part of the home exercises, participants are invited to write a diary of their perceptions of the baby’s movements and cues, and a dialogue with the baby to further enhance interoception (embodied awareness and inward focus), sense of presence, sensitivity and reflective functioning, connection with the baby, and relaxation. In addition, they are invited to reflect upon these experiences and practice mindfulness and baby connect whenever possibly in their daily life activities. The recommended amount of daily home exercises is approximately 30 minutes, 6 days a week. The benefits of these exercises and the importance of continued practice are explained during the sessions.

Table 1 Components of the Prenatal Mindfulness Relationship-Based (PMRB) program.

Sessions Focus of session
number

1 Discovering the present moment
2 Everything is mindfulness
3 Discovering embodiment, stress and how it affects us
4 Learning acceptance and emotional availability
5 Self-compassion, self-love and intentionality
6 Cultivating nurturing emotions and conscious communication in the womb
7 Letting go
8 A mindful pregnancy, birth and life
9 Post-partum reunion and birth story

c) Who will deliver the intervention
The intervention is delivered by myself, the program creator, who is also the PhD candidate piloting it. I am a certified Youth Mindfulness practitioner, clinical psychologist, MA, and author.
d) Mode of delivery
The PMRB program is delivered on an online platform (Zoom).
e) Number of times the intervention is delivered and over what period of time
The program is delivered in 9 sessions. The traditional number of weekly sessions of a mindfulness-based intervention – eight - has been kept, and the length of each weekly session from 20+ weeks to approximately 36-week gestation is two hours. A group reunion session was supposed to be held 10-12 weeks post-partum, before the third survey, but the proposed time was not suitable for all the new mothers busy with their newborn infants. Hence, individual and pair sessions are offered.
f) The location/setting where the intervention occurs
Online, Zoom, Australia.
g) Strategies used to assess or monitor adherence or fidelity of the intervention
Fidelity was not monitored using audio or video recording to ensure confidentiality. Transcripts were used for the qualitative analysis.
Compliance was measured by noting participant attendance and by questions about the frequency and length of the mindfulness practice during the last week. It was recommended not to miss more than two sessions. Most participants missed 1 or 2 sessions and all participants completed the prenatal program. Only one participant did not attend the postpartum session and completed the follow-up due to unknown reasons. The importance of continued practice and a minimum period of six weeks to induce brain and habitual pattern changes and mental health improvements was explained (Bowen et al., 2014; Guardino et al., 2014; Woolhouse et al., 2014).

References:

Bowen, A., Baetz, M., Schwartz, L., Balbuena, L., & Muhajarine, N. (2014). Antenatal group
therapy improves worry and depression symptoms. The Israel Journal of Psychiatry and
Related Sciences, 51 (3), 2260231.
Guardino, C.M., Dunkel Schetter, C., Bower, J.E., Lu M.C., & Smalley, S.L. (2014).
Randomised controlled pilot trial of mindfulness training for stress reduction during
pregnancy. Psychology and Health. 29 (3), 334-49. doi: 10.1080/08870446.2013.852670.
Epub 2013 Nov 1. PMID: 24180264; PMCID: PMC4160533.
Kabat-Zinn, J., Massion, A.O., Kristeller, J., Peterson, L.G., Fletcher K.E., Pbert, L.,
Lenderking, W.R., & Santorelli, S. F. (1992). Effectiveness of a meditation-based stress
reduction program in the treatment of anxiety disorders. American Journal of Psychiatry.
149 (7), 936-43.
Sansone, A. (2021). Sansone, A. (2021). Cultivating mindfulness to raise children who thrive:
Why human connection from before birth matters. Routledge.
Woolhouse, H., Mercuri, K., Judd, F., & Brown, S. J. (2014). Antenatal mindfulness
intervention to reduce depression, anxiety and stress: a pilot randomised
controlled trial of the MindBabyBody program in an Australian tertiary maternity
hospital. BMC Pregnancy and Childbirth, 14, 369.

Intervention code [1]

Treatment: Other

Comparator / control treatment

No control group/Feasibility study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Maternal mindfulness

Maternal mindfulness was measured using the Five Facets Mindfulness Questionnaire (FFMQ) (Baer et al., 2006),

Timepoint [1]

Time point 1: 20+ weeks gestation
Time point 2: Approximately 36-week gestation
Time point 3: 10-12 weeks postpartum (follow-up)

Secondary outcome [1]

Interoception
Maternal interoception or interoceptive awareness was measured by using the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAYA) (Melhing et al., 2018).

Timepoint [1]

Time point 1: 20+ weeks gestation
Time point 2: Approximately 36-week gestation
Time point 3: 10-12 weeks postpartum (follow-up)

Secondary outcome [2]

Mother-infant relationship during pregnancy

Mother-infant relationship during pregnancy was measured using the Maternal-Foetal Attachment Scale (MFAS; Cranley, 1981

Timepoint [2]

Time point 1: 20+ weeks gestation
Time point 2: Approximately 36-week gestation

Secondary outcome [3]

Mother-infant relationship postpartum

It was measured using the Emotional Availability Self-Report (EA-SR; Biringer et al., 2002; Vliegen, et al., 2005), an outcome measure assessing maternal emotional availability, which is considered a good indicator of a favourable mother-infant relationship during the first year of a child’s life (Vliegen et al., 2009).

Timepoint [3]

Time point 3: 10-12 weeks postpartum (follow-up)

Secondary outcome [4]

Maternal Depression

Maternal depression was assessed using the Edinburgh Postnatal Depression Scale (EPDS),

Timepoint [4]

Time point 1: 20+ weeks gestation
Time point 2: Approximately 36-week gestation
Time point 3: 10-12 weeks postpartum (follow-up)

Secondary outcome [5]

Anxiety and Stress

The second measure of maternal mental health was the Depression Anxiety Stress Scale-21 Short Form (DASS-21; Lovibond & Lovibond, 1995).

Timepoint [5]

Time point 1: 20+ weeks gestation
Time point 2: Approximately 36-week gestation
Time point 3: 10-12 weeks postpartum (follow-up)

Eligibility

Key inclusion criteria

Pregnant women were eligible to participate in the study if they were: (a) aged 18 or older; (b) 20+ weeks gestation at onset of program; (c) had sufficient English and intellectual proficiency to understand and complete the questionnaires; (d) did not receive antenatal care from specialised clinics, irrespective of parity and ethnicity; (e) from Australia

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Pregnant women were not eligible to participate in the study if they were: (a) younger than 18-year old; (b) 20- weeks gestation or 26+ gestation at onset of program; (c) did not have sufficient English and intellectual proficiency to understand and complete the questionnaires; (d) received antenatal care from specialised clinics, irrespective of parity and ethnicity; (e) from Australia

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

It is an e-health feasibility study without a controlled group

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The online 9-session mindfulness-based intervention study is a non-randomised feasibility study. Feasibility studies need a minimum of 12 participants as they only test the feasibility of an intervention. The study has 13 participants. Measurements of mindfulness, mental health, in particular depression, anxiety and stress, mother-foetus relationship, and interception were taken pre (20+ weeks gestation) and post-intervention (approximately 36 weeks gestation) through the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF; Bohlmeijer, et al., 2011), Postnatal Depression Scale (EPDS; Cox, et al., 1987), the Depression Anxiety Stress Scale-21 Short Form (DASS-21; Lovibond & Lovibond, 1995 ), the Maternal-Foetal Attachment Scale (MFAS; Cranley, 1981), and the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA; Mehling et al., 2012). Same measurements, excluding the mother-foetus relationship and including the mother-infant emotional availability, were taken 10-12 weeks postpartum through the same questionnaires. The mother-infant emotional availability was measured through the Emotional Availability Self-Report (EAS) (EA-SR; Vliegen, et al., 2005). Data was collected via a secure online survey platform called Qualtrics and the link to the platform and information about the study were provided on the study advertisement. Analysis of outcome data for the non-randomised trial involves One-Way Repeated Measures Analysis of Variance (ANOVA) to test for statistically significant differences between three related sample means at three separate points in time - baseline, post-intervention and postpartum mean scores.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

31/03/2022

Date of last participant enrolment

Anticipated

Actual

5/01/2023

Date of last data collection

Anticipated

Actual

7/01/2023

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Bond University

Address [1]

Gold Coast, Queensland, 4229

Country [1]

Australia

Primary sponsor type

University

Name

Bond University

Address

Gold Coast, Queensland, 4229

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Bond University

Address [1]

Gold Coast, Queensland, 4229

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bond University Human Research Ethics Committee

Ethics committee address [1]

Bond University, Gold Coast, Queensland 4229

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

10/01/2022

Ethics approval number [1]

AS03534:

Summary

Brief summary

The primary purpose of this study was to test the hypothesis, through a e-health feasibility study (Study 2), that the Prenatal Mindfulness Relationship-Based (PMRB) program could enhance the mental health of pregnant and new mothers as measured by multiple dimensions of psychological health and the relationship with their infants during pregnancy and postpartum, with positive impacts on gestation, birth and infant outcomes as reported by the mothers in a Post-Birth Questionnaire. The study also aimed to provide further information, based on available literature, about the influence of maternal interoception (embodied awareness) on maternal mental health, in particular depression, anxiety, and stress, mindfulness, and mother-infant relationship during pregnancy and post-birth, in particular emotional availability, which can contribute to the development of mind-body approaches to pregnancy healthcare.This study addressed the following research questions (RQ): RQ1: Would participation in the PMRB program lead to higher levels of mindfulness, 
better mental health (as indicated by lower levels of anxiety, depression, and stress), more favorable mother infant-relationship, and higher interoception during pregnancy (in particular emotional availability), compared to baseline? RQ2: Would participation in the PMRB program lead to higher levels of mindfulness, better mental health (as indicated by lower levels of anxiety, depression, and stress), more favorable mother- infant relationship (referred to by the Emotional Availability Self-Report -EA-SR; Vliegen et al., 2005 as emotional availability), and higher interoception post-birth? RQ3: Open-ended - “How has the PMRB program supported (or not supported) you during pregnancy, labour and birth and the first postpartum trimester?” The specific hypothesis are: 1) Participation in the PMRB program would lead to higher levels of mindfulness, better mental health (as indicated by lower levels of anxiety, depression, and stress), more favorable mother infant-relationship, and higher interoception during pregnancy (in particular emotional availability), compared to baseline; 2) Participation in the PMRB program would lead to higher levels of mindfulness, better mental health (as indicated by lower levels of anxiety, depression, and stress), more favorable mother- infant relationship (referred to by the Emotional Availability Self-Report -EA-SR; Vliegen et al., 2005 as emotional availability), and higher interoception post-birth; 3) The PMRB program would support women during their pregnancy, labour and birth, and the first postpartum trimester.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Antonella Sansone-Southwooth

Address

Bond University | Gold Coast, Queensland, 4229, Australia

Country

Australia

Phone

+61 755951111

Fax

[email protected]

Contact person for public queries

Name

Antonella Sansone-Southwood

Address

Bond University, Gold Coast, Queensland, 4229, Australia

Country

Australia

Phone

+61 755951111

Fax

[email protected]

Contact person for scientific queries

Name

Antonella Sansone-Southwood

Address

Bond University, Gold Coast, Queensland, 4229

Country

Australia

Phone

+61 755951111

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Only de identified data will be available

When will data be available (start and end dates)?

End of August/September 2023 when I expect the articles to be published and available for 5 years following main results publication

Available to whom?

De identified data will be available in a cloud share system such as OSF by signing in via Bond University
https://accounts.osf.io/login?service=https://osf.io/5shc3/

Available for what types of analyses?

The repeated ANOVA analysis

How or where can data be obtained?

A cloud store system will be available such as OSF above

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details	Attachment
18929	Study protocol	[email protected]	In the cloud store system - most journals ask for ... [More Details]	385750-(Uploaded-30-04-2023-19-28-44)-Study-related document.docx
18964	Informed consent form	[email protected]	In the cloud store system - most journals ask for ... [More Details]	385750-(Uploaded-30-04-2023-15-51-21)-Study-related document.docx
18965	Ethical approval	[email protected]	In the cloud store system - most journals ask for ... [More Details]	385750-(Uploaded-30-04-2023-15-54-38)-Study-related document.pdf
18966	Other	[email protected]	Participant Information Sheet In the cloud store ... [More Details]	385750-(Uploaded-30-04-2023-15-58-14)-Study-related document.docx
18968	Clinical study report	[email protected]	In the cloud store system - most journals ask for ... [More Details]

Results publications and other study-related documents

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No additional documents have been identified.

Trial Review

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